Abstract Highlighting Long-Term Follow Up Data
from the DYNAMO® Study of Duvelisib in Patients with
Double-Refractory Follicular Lymphoma Selected for Oral
Presentation
Verastem, Inc. (NASDAQ:VSTM), focused on discovering and
developing drugs to improve the survival and quality of life of
cancer patients, today announced an abstract featuring long-term
follow up data from the DYNAMO® study evaluating duvelisib in
patients with follicular lymphoma (FL) has been selected for oral
presentation at the 22nd Congress of the European Hematology
Association (EHA) being held June 22-25, 2017 in Madrid, Spain. In
addition, an abstract describing Phase 2 data, also from the DYNAMO
study, evaluating duvelisib in patients with small lymphocytic
lymphoma (SLL) has been selected for an e-poster presentation at
the meeting. DYNAMO is a Phase 2 clinical trial evaluating the
safety and efficacy of duvelisib in patients with indolent
non-Hodgkin lymphoma (iNHL) that are double refractory to both
rituximab and chemotherapy.
“In the previously reported Phase 2 DYNAMO study results,
duvelisib monotherapy demonstrated statistically significant
clinical activity in iNHL patients, acheiving the primary endpoint
with a 46% overall response rate, and was generally well tolerated
with a manageable safety profile with appropriate risk mitigation,”
said Hagop Youssoufian, MSc, MD, Head of Hematology and Oncology
Development at Verastem. “We look forward to presenting the
long-term follow up data in June.”
Details for the presentations at EHA 2017 are:
Oral Presentation
Title: DYNAMO: A Phase 2 Study Demonstrating the Clinical
Activity of Duvelisib in Patients with Double-Refractory Follicular
LymphomaPresenter: Pier Luigi Zinzani, MD, PhD, University
of Bologna Institute of HematologyAbstract code:
S777Topic: Indolent Non-Hodgkin lymphoma –
ClinicalSession title: Follicular lymphoma –
ClinicalLocation: Hall CDate and time: Sunday, June
25, 2017, 8:45 – 9:00 CET
A copy of the oral presentation slides will be available here
following the conclusion of the oral presentation.
E-Poster Presentation
Title: DYNAMO: The Clinical Activity of Duvelisib in
Patients with Double-Refractory Small Lymphocytic Lymphoma in a
Phase 2 StudyAbstract code: E1130Topic: Indolent
Non-Hodgkin lymphoma – ClinicalLocation: e-poster
screensDate and time: Friday, June 23, 2017 from 9:30 CET to
Saturday, June 24, 2017 at 19:00 CET
A copy of the e-poster presentation will be available here
following the conclusion of the meeting.
About the Tumor Microenvironment
The tumor microenvironment encompasses multiple tumor and
non-tumor cell populations and an extracellular matrix that support
cancer cell survival. This includes immunosuppressive regulatory
T-cells, myeloid-derived suppressor cells, tumor-associated
macrophages, cancer-associated fibroblasts and extracellular matrix
proteins that can hamper the entry and therapeutic benefit of
cytotoxic T-cells and anti-cancer drugs. In addition to targeting
the proliferative and survival signaling of cancer cells,
Verastem’s product candidates, including duvelisib and defactinib,
also target the tumor microenvironment to potentially improve a
patient’s response to therapy.
About Duvelisib
Duvelisib is an investigational, dual inhibitor of
phosphoinositide 3-kinase (PI3K)-delta and PI3K-gamma, two enzymes
that are known to help support the growth and survival of malignant
B-cells and T-cells. PI3K signaling may lead to the proliferation
of malignant B-cells and is thought to play a role in the formation
and maintenance of the supportive tumor microenvironment.1,2,3
Duvelisib is currently being evaluated in late- and mid-stage
clinical trials, including DUO™, a randomized, Phase 3 monotherapy
study in patients with relapsed or refractory CLL,4 and DYNAMO™, a
single-arm, Phase 2 monotherapy study in patients with refractory
iNHL that achieved its primary endpoint of ORR upon top-line
analysis of efficacy data.5 Duvelisib is also being evaluated for
the treatment of hematologic malignancies through
investigator-sponsored studies, including T-cell lymphoma.6
Information about duvelisib clinical trials can be found on
www.clinicaltrials.gov.
About Verastem, Inc.
Verastem, Inc. (NASDAQ: VSTM) is a biopharmaceutical company
focused on discovering and developing drugs to improve outcomes for
patients with cancer. Verastem is currently developing duvelisib, a
dual inhibitor of PI3K-delta and PI3K-gamma, which has successfully
met its primary endpoint in a Phase 2 study in iNHL and is
currently being evaluated in a Phase 3 clinical trial in patients
with CLL. In addition, Verastem is developing the FAK inhibitor
defactinib, which is currently being evaluated in three separate
clinical collaborations in combination with immunotherapeutic
agents for the treatment of several different cancer types,
including pancreatic cancer, ovarian cancer, non-small cell lung
cancer, and mesothelioma. Verastem’s product candidates seek to
treat cancer by modulating the local tumor microenvironment,
enhancing anti-tumor immunity and reducing cancer stem cells. For
more information, please visit www.verastem.com.
Verastem, Inc. forward-looking statements notice:
This press release includes forward-looking statements about
Verastem's strategy, future plans and prospects, including
statements regarding the development and activity of Verastem's
investigational product candidates, including duvelisib and
defactinib, and Verastem's PI3K and FAK programs generally, the
structure of our planned and pending clinical trials and the
timeline and indications for clinical development, and our rights
to develop or commercialize our product candidates. The words
"anticipate," "believe," "estimate," "expect," "intend," "may,"
"plan," "predict," "project," "target," "potential," "will,"
"would," "could," "should," "continue," and similar expressions are
intended to identify forward-looking statements, although not all
forward-looking statements contain these identifying words. Each
forward-looking statement is subject to risks and uncertainties
that could cause actual results to differ materially from those
expressed or implied in such statement. Applicable risks and
uncertainties include the risks that the preclinical testing of
Verastem's product candidates and preliminary or interim data from
clinical trials may not be predictive of the results or success of
ongoing or later clinical trials; that data may not be available
when expected; that enrollment of clinical trials may take longer
than expected; that our product candidates will cause unexpected
safety events or result in an unmanageable safety profile as
compared to their level of efficacy; that duvelisib will be
ineffective at treating patients with lymphoid malignancies; that
Verastem will be unable to successfully initiate or complete the
clinical development of its product candidates; that the
development of Verastem's product candidates will take longer or
cost more than planned; that Verastem may not have sufficient cash
to fund its contemplated operations; that Verastem or Infinity
Pharmaceuticals, Inc. will fail to fully perform under the
duvelisib license agreement; that Verastem will not pursue or
submit regulatory filings for its product candidates; and that
Verastem's product candidates will not receive regulatory approval,
become commercially successful products, or result in new treatment
options being offered to patients. Other risks and uncertainties
include those identified under the heading "Risk Factors" in
Verastem's Annual Report on Form 10-K for the year ended December
31, 2016 and in any subsequent filings with the U.S. Securities and
Exchange Commission. The forward-looking statements contained in
this press release reflect Verastem's views as of the date of this
release, and Verastem does not undertake and specifically disclaims
any obligation to update any forward-looking statements.
References
1 Winkler D.G., Faia K.L., DiNitto J.P. et al. PI3K-delta and
PI3K-gamma inhibition by IPI-145 abrogates immune responses and
suppresses activity in autoimmune and inflammatory disease models.
Chem Biol 2013; 20:1-11.2 Reif K et al.Cutting Edge: Differential
Roles for Phosphoinositide 3 kinases, p110-gamma and p110-delta, in
lymphocyte chemotaxis and homing. J Immunol 2004:173:2236-2240.3
Schmid M et al. Receptor Tyrosine Kinases and TLR/IL1Rs
Unexpectedly activate myeloid cell PI3K, a single convergent point
promoting tumor inflammation and progression. Cancer Cell
2011;19:715-727.4 www.clinicaltrials.gov, NCT020045225
www.clinicaltrials.gov, NCT018828036 www.clinicaltrials.gov,
NCT02783625, NCT02783625, NCT02158091
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version on businesswire.com: http://www.businesswire.com/news/home/20170518005559/en/
Verastem, Inc.Brian Sullivan, 781-292-4214Director,
Corporate Developmentbsullivan@verastem.com
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